NCT02542683 · Columbia University
Physical Activity and Cognitive Development in Children
What this study is about
1. Compare physical activity and cognitive functions between children having cardiac surgery with an age-matched group of children undergoing non-cardiac surgery, as well as otherwise healthy siblings or best buddies (or age and gender-matched children if no siblings or best buddies available) before surgery and after surgery or six months following initial assessment. 2.
View original scientific description
1. Compare physical activity and cognitive functions between children having cardiac surgery with an age-matched group of children undergoing non-cardiac surgery, as well as otherwise healthy siblings or best buddies (or age and gender-matched children if no siblings or best buddies available) before surgery and after surgery or six months following initial assessment. 2. Determine the effects of a structured physical activity program for 6 months following surgery on cognitive functions and adaptive behavior in children following congenital cardiac surgery. 3. Determine the effects of a structured physical activity program for 12 months following surgery on cognitive functions and adaptive behavior in children following congenital cardiac surgery. 4. We will perform exploratory analysis to determine whether any effects of a 12-months structured physical activity program on cognitive functions and adaptive behavior persist beyond 12 months after cessation of the program.
Interventions
OTHER
structured physical activity program
a structured modest physical activity program
Primary outcome measures
Intelligence Quotient (IQ) score
Time frame: Up to 24 months from the time of assessment at baseline
Global neurocognitive function assessment with IQ score using the Wechsler Preschool and Primary Scale of Intelligence (WPPSI 4): at baseline and up to 24 months later.
Score on the NIH Toolbox Early Childhood Battery
Time frame: Up to 24 months from the time of assessment at baseline
Domain-specific neurocognitive function: Memory, learning, attention, executive function, language and motor function using the NIH Toolbox Early Childhood. Scores from each domain in the battery will be used . Domain-specific scores obtained at baseline, then every 6 months up to 24 months later.
Score on Adaptive Behavior Assessment System, 3rd edition (ABAS-III)
Time frame: Up to 24 months from the time of assessment at baseline
Adaptive behavior: Parental reports of behavior using ABAS-III, collected at baseline and then every 6 months up to 24 months later.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Congenital Heart Diseases (CHD) Cohort: All children with congenital cyanotic cardiac diseases scheduled for congenital cardiac surgery who are older than 30 months of age.
- Non-CHD, Surgical Cohort: All children 30 months or older who are undergoing non-cardiac surgery at Columbia University Medical Center (CUMC), including pediatric general surgery, urological surgery, ear, nose and throat (ENT) surgery, plastic surgery and eye surgery. These children will be recruited before surgery.
- Non-surgical cohort:
- Sibling of children of CHD patients within 12 months in age, and 30 months of age or older.
- Relatives of CHD patients of the same gender within 12 months in age and 30 months of age or older.
- Best buddies of CHD children within 12 months in age and 30 months of age or older.
- Children who are matched by age ±6 months who are 30 months of age or older, gender, level parental education and language spoken at home
Exclusion criteria
- Children with known chromosomal syndromes, or known syndromes including but not limited to DiGeorge, Trisomy 21, WIlliams, Noonan and Turner.
- Children with known physical disabilities.
- Children with known history of central nervous system (CNS) injury including stroke, birth asphyxia, seizure disorder, intraventricular hemorrhage.
- Children with abnormal neurological exam by a pediatric physician or nurse practitioner, and confirmed by a pediatric neurologist.
- Children with tricuspid regurgitation on echocardiography or on cardiac angiography that is moderate or greater.
- Children with moderate or greater decrease in ventricular function on echocardiography or on cardiac angiography.
- Children with baseline room air oxygen saturation below 80%.
- Children who are treated for dysrhythmias or are pacemaker-dependent.
- Children with history of prematurity. (Non-surgical cohort)
- Children with history of more than one episode of hospitalization. (Non-surgical cohort)
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 4, 2026 · Source of record for eligibility and locations